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Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:

To determine the genitourinary safety of dapivirine gel (0.05%), the endpoint was the proportion of men subjected to dapivirine gel or placebo gel experiencing specific, protocol-defined safety events during the study (see description). [ Time Frame: 8 days ]

Any evidence of Grade 2 or higher male genitourinary adverse event(s) as defined by the DAIDS AE Grading Table Version 1.0, December 2004 (Clarification dated August 2009), Addendum 2 (Male Genital Toxicity Table for Use in Topical Microbicide Studies)

Secondary Outcome Measures:

To assess the pharmacokinetics in plasma following 7 days of once daily penile application of dapivirine gel (0.05%) [ Time Frame: 8 days ]

Dapivirine concentrations in blood

To assess the systemic safety following 7 days of once daily penile application of dapivirine gel (0.05%) [ Time Frame: 8 days ]

Grade 2 and higher clinical and laboratory adverse events as defined by the DAIDS AE Grading Table Version 1.0, December 2004 (Clarification dated August 2009) and the Male Genital Toxicity Table for Use in Topical Microbicide Studies

To assess the acceptability following 7 days of once daily penile application of dapivirine gel (0.05%) [ Time Frame: 8 days ]

Proportion of participants who at their Final Clinic Visit report via the acceptability questionnaire, that they would be very likely to use the candidate microbicide during sexual intercourse in the future

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

At least 18 years of age at Screening, verified per site standard operating procedure (SOP)

Able and willing to provide written informed consent to be screened for and take part in the study

At Screening, able and willing to provide adequate locator information, as defined per site SOP

Able and willing to communicate in written and spoken English

HIV-uninfected at Screening per Algorithm in Appendix II

In general good health, according to the clinical judgment of the Investigator of Record (IoR) or designee

Willing to abstain from vaginal, oral and anal intercourse (including receptive anal intercourse), even with a condom; masturbation, and other activities that may cause irritation or injury to the penis during study participation

Willing to abstain from using any genitally-applied preparations (except use of usual cleansing products for genital hygiene) other than the study product during study participation

Willing to abstain from non-urgent surgical procedures of the penis/GU area for the duration of study participation (e.g. circumcision)

At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, or genital products for the duration of study participation (until all follow-up visits are completed)

Exclusion Criteria:

Participant report of any of the following:

Known adverse reaction to any of the study products or components of the study products (ever)

Calculated creatinine clearance less than 80 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140-age in years) x (weight in kg) x 0.85/72 x serum creatinine in mg/dL Note: Otherwise eligible participants with any of the above exclusionary laboratory results may be re-tested. If a participant is re-tested and a non exclusionary result is documented within 30 days of providing informed consent for Screening, the participant may be enrolled.

At Screening or Enrollment, diagnosed with STI or reproductive tract infection (RTI) requiring treatment, per current Centers for Disease Control and Prevention (CDC) guidelines

At Screening or Enrollment, has a clinically apparent Grade 1 or higher genital exam finding (observed by study staff)

At Screening or Enrollment, has Grade 1 or higher genital or urinary symptoms

Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277640

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Chair:

Ross D. Cranston, MD, FRCP

Division of Infectious Diseases, University of Pittsburgh Medical Center